Rifampin Capsules Recalled Due to Failed Impurity and Degradation Specification
Amerisource Health Services is recalling Rifampin 150 mg capsules because they failed to meet impurity and degradation specifications. The recall affects 1,568 cartons distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves failed specifications for impurities and degradation in a prescription medication. Although no illnesses or injuries have been reported and the specific nature of the impurities is not detailed in the source, pharmaceutical purity defects represent a risk-of-harm situation where injury has not yet been reported.
Plain-English summary
Amerisource Health Services LLC is recalling Rifampin (RIFAMPIN) capsules, 150 mg, distributed nationwide because the medication failed to meet the U.S. Pharmacopeial Convention (USP) specifications for impurities and degradation. The affected product consists of 1,568 cartons bearing lot number 1008111 with an expiration date of 01/31/2024, identified by NDC 60687-575-21 (carton) and NDC 60687-575-11 (unit dose).
When a drug fails impurity and degradation specifications, it means the product does not meet established quality standards for purity and stability. This is a Class II recall, indicating the FDA has determined that use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious harm is remote.
Patients and healthcare providers who have received this lot of Rifampin should contact their pharmacist or healthcare provider. Do not discard the medication; return it to the pharmacy where it was dispensed for proper disposal and to discuss alternative treatment options with your healthcare provider.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 1,568
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1008111
- Exp. Date 01/31/2024
Distribution
Distributed nationwide across the United States.
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